Malaysia MDA Describes China NMPA IVD Regulatory Reliance Pilot

By Yu Seen Ng and Evangeline Loh

IVD regulatory reliance program

Malaysia’s  Medical Device Authority (MDA) announced an in vitro diagnostic (IVD) device regulatory reliance program. Additional details indicate IVDs from Malaysia would have access to the China Green Channel program, and IVDs from China would be subject to the MDA Verification Pathway. Requirements for both include that the manufacturer must own the facility where their IVDs are manufactured and have authorization to market the IVD in their home country. IVDs manufactured in Malaysia and IVDs made in China would benefit from reduced review times of 60 working days and 30 days, respectively. 

Pilot program for two months

The MDA (July 30) shared details of the two-month IVD Regulatory Reliance Programme pilot, from July 30 through September 30. For the next two months, the pilot program will accept six applications for manufacturers in Malaysia and six applications for manufacturers in China. The IVDs manufactured in Malaysia must be Class A or higher and authorized by China's National Medical Products Administration (NMPA. The IVD manufactured in China must be Class II approved by the provincial authority (MPA) or Class III approved by the NMPA.

Appendix for Malaysia verification pathway

The second page is an appendix flow diagram provided to explain the verification process for IVDs from Chinese manufacturers. Even in this pilot, the local authorized representative is involved. After the MDA screens the application, applications accepted in the pilot would be reviewed by a conformity assessment body (CAB) appointed by the MDA. The CAB performs the verification assessment. A satisfactory CAB review (certificate and report) moves the application to MDA evaluation. A successful MDA review results in the registration certificate and listing in the Medical Device Register (MDAR).

MDA and NMPA commitment to medical device access

The pilot program is open for 60 days, and a total of 12 applications will be accepted. The pilot underscores the commitment of the MDA and NMPA in this initiative. Even if you are not a manufacturer based in China, the appendix provides regulatory details of the verification pathway. 

We applaud regulatory reliance initiatives aimed at advancing global medical device access.